Quality Assurance Manager

GLOBAL NAPI PHARMACEUTICALS - 6th Of October, Giza

107
Applicants for
1 open position
Experience Needed:
More than 20 years
Career Level:
Manager
Job Type:
Full Time
Salary:
Confidential
Education Level:
Bachelor's Degree at least
Languages:
English
Vacancies:
1 open position
About the Job

Quality Activities :

  • Ensures that all manufacturing process is following strictly the GMP regulations, securing, in parallel, that it will be in line with the approved SOP.
  • Authorizes the final release of the products.
  • Prevents any incident, before occurrence, from happening that may alter the quality of the product which in return can cause product turning back or recall or even clients’ complains.
  • Ensures that required documents are available when needed.
  • Sets procedures that ensure the correct handling of materials and documents.
  • Performs self-audits on a regular basis.
  • Performs external-audits according to Annual Plan.
  • Conducts training programs on a scheduled basis.
  • Solves technical problems related to product quality.
  • Ensures the appropriate filing and archiving of documents.
  • Works with the manufacturing management improve procedures related to quality.
  • Reviews and corrects or completes documents relative to quality technical documents.
  • Secures the calibration of all reading devices, as well as, the calibration and validation of all equipment by inspecting them on a routine basis.
  • Makes sure that no change in the production process or the acquirement of raw materials can take place in any field without taking the appropriate measures for validation and approval.
  • Reviews and approves the batch records prepared by production & Q.A. department.
  • Manages & supervises departmental employees, assigns work and special projects, monitors workload and productivity, evaluates performance and promotes staff training and development.
  • Identifies the required technical training and cooperates closely with HR Manager on issues of training, development, vacation schedules and makes proposals for hiring, firing, promotions, bonus and salary increases.
  • Coordinates with the departments of Production, Warehouse, Engineering and HR to achieve departmental and company objectives.
  • Secures the compliance with the quality, environment, safety requirements according to national and international standard (ISO 9001, 14001).
  • Identifies, records and updates the various aspects within the department and their impact on the environment.
  • Participates in setting implementing and amending the environmental programs.
  • Determines and identifies the emergency situations in the department.
  • Ensures that the disposal of waste in the department is effected in line with the waste management policy.
  • Carries out periodical environmental awareness sessions to the employees in the department.
  • Approves all Product Quality related documents

Compliance Activities

  • Assures the compliance of Methods of Analysis to the Registered Files.
  • Assures the compliance of Products Specifications to the Registered Files.
  • Assures the compliance of know how of Products with the Registered Files.

Validation Responsibilities

  • Manages the preparation and performance of Process Validation Protocols, Cleaning Validation, and Machines / Utilities Qualifications in coordination with QC, Production, and Engineering
  • Manages the preparation and performance of Computer Validation Protocols in coordination with IT and any related Department.
Job Requirements
  • A Bachelor of Sc. of Pharmaceutical Sciences is required.
  • Not less than 20 Professional years of experience.

About this Company

Since its establishment in 1997, Global Napi Pharmaceuticals was self-committed to present the highest quality of medicines to the patients. A principle that challenged us to offer the competitive environment and do all the efforts to satisfy patients, employees, business... (More)

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